SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019

SECTION 1. IDENTIFICATION
Product name:

Pancrelipase (High / Low Lipase) Formulation

Manufacturer or supplier's details
Company name of supplier: Organon & Co.
Address: 30 Hudson Street, 33nd floor
Jersey City, New Jersey, U.S.A 07302
Telephone: 1-551-430-6000
Emergency telephone: 1-215-631-6999
E-mail address: EHSSTEWARD@organon.com
Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
SECTION 2. HAZARDS IDENTIFICATIONGHS classification in accordance with the OSHA Hazard Communication Standard (29 CFR
1910.1200)
Combustible dust
Skin irritation:

Category 2

Eye irritation:

Category 2A

Respiratory sensitization:

Category 1

GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

May form combustible dust concentrations in air.
H315 Causes skin irritation.
H319 Causes serious eye irritation.
H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled.

Precautionary Statements:

Prevention:
P261 Avoid breathing dust, fume, gas, mist, vapors or spray.
P264 Wash skin thoroughly after handling.
P280 Wear protective gloves, eye protection and face protection.
P285 In case of inadequate ventilation wear respiratory protection.
Response:
1 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019

P302 + P352 IF ON SKIN: Wash with plenty of soap and water.
P304 + P341 IF INHALED: If breathing is difficult, remove person to fresh air and keep comfortable for breathing.
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water
for several minutes. Remove contact lenses, if present and easy
to do. Continue rinsing.
P332 + P313 If skin irritation occurs: Get medical attention.
P337 + P313 If eye irritation persists: Get medical attention.
P342 + P311 If experiencing respiratory symptoms: Call a doctor.
P362 + P364 Take off contaminated clothing and wash it before
reuse.
Disposal:
P501 Dispose of contents and container to an approved waste
disposal plant.
Other hazards
None known.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Pancrelipase
Talc
StarchSucrose
Diethyl phthalate

CAS-No.
53608-75-6
14807-96-6
9005-25-8
57-50-1
84-66-2

Concentration (% w/w)
72
8.6
2.9
2.9
2.1

SECTION 4. FIRST AID MEASURES
General advice:

In the case of accident or if you feel unwell, seek medical
advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.

If inhaled:

In case of skin contact:

In case of eye contact:

If inhaled, remove to fresh air.
If not breathing, give artificial respiration.
If breathing is difficult, give oxygen.
Get medical attention.
In case of contact, immediately flush skin with plenty of water
for at least 15 minutes while removing contaminated clothing
and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
In case of contact, immediately flush eyes with plenty of water
for at least 15 minutes.
If easy to do, remove contact lens, if worn.
2 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

If swallowed:

Most important symptoms
and effects, both acute anddelayed:Protection of first-aiders:

Notes to physician:

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019

Get medical attention.
If swallowed, DO NOT induce vomiting.
Get medical attention if symptoms occur.
Rinse mouth thoroughly with water.
Causes skin irritation.
Causes serious eye irritation.
May cause allergy or asthma symptoms or breathing difficulties if inhaled.
Excessive exposure may aggravate preexisting asthma andother respiratory disorders (e.g. emphysema, bronchitis, reactive airways dysfunction syndrome).
First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).
Treat symptomatically and supportively.

SECTION 5. FIRE-FIGHTING MEASURES
Suitable extinguishing media:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemicalHigh volume water jet

Unsuitable extinguishingmedia
Specific hazards during firefighting::

Avoid generating dust; fine dust dispersed in air in sufficientconcentrations, and in the presence of an ignition source is apotential dust explosion hazard.
Do not use a solid water stream as it may scatter and spread
fire.
Exposure to combustion products may be a hazard to health.

Hazardous combustion products:

Carbon oxides
Nitrogen oxides (NOx)
Sulfur oxides

Specific extinguishing methods:

Special protective equipment
for fire-fighters:

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
Use water spray to cool unopened containers.
Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.
In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

SECTION 6. ACCIDENTAL RELEASE MEASURES
Personal precautions, protec- :tive equipment and emergency procedures

Use personal protective equipment.
Follow safe handling advice (see section 7) and personal
protective equipment recommendations (see section 8).

Environmental precautions

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages:

3 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019

cannot be contained.
Methods and materials forcontainment and cleaning up:

Surround spill with absorbents and place a damp coveringover the area to minimize entry of the material into the air.
Add excess liquid to allow the material to enter into solution.
Soak up with inert absorbent material.
Avoid dispersal of dust in the air (i.e., clearing dust surfaces
with compressed air).
Dust deposits should not be allowed to accumulate on
surfaces, as these may form an explosive mixture if they are
released into the atmosphere in sufficient concentration.
Clean up remaining materials from spill with suitable
absorbent.
Local or national regulations may apply to releases anddisposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need todetermine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

SECTION 7. HANDLING AND STORAGE
Technical measures:

Local/Total ventilation
Advice on safe handling::

Conditions for safe storage:

Materials to avoid:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
Use only with adequate ventilation.
Do not get on skin or clothing.
Avoid breathing dust, fume, gas, mist, vapors or spray.
Do not swallow.
Do not get in eyes.
Wash skin thoroughly after handling.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure
assessment
Keep container tightly closed.
Already sensitized individuals, and those susceptible
to asthma, allergies, chronic or recurrent respiratory disease,should consult their physician regarding working withrespiratory irritants or sensitizers.
Minimize dust generation and accumulation.
Keep container closed when not in use.
Keep away from heat and sources of ignition.
Take precautionary measures against static discharges.
Take care to prevent spills, waste and minimize release to theenvironment.
Keep in properly labeled containers.
Keep tightly closed.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents

4 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Ingredients with workplace control parameters
Components

CAS-No.

Pancrelipase

53608-75-6

Value type
(Form ofexposure)
TWA

Talc

14807-96-6

TWA (Dust)

Starch

9005-25-8

Sucrose57-50-1

Diethyl phthalate

Engineering measures

84-66-2:

TWA (Respirable)
TWA (Respirable particulate matter)
TWA
TWA (Respirable)
TWA (total)
TWA (total
dust)
TWA (respirable fraction)
TWA
TWA (Respirable)
TWA (total)
TWA (total
dust)
TWA (respirable fraction)
TWA
TWA

Control parameters / Permissible
concentration
OEB 3 (>= 10 <100 µg/m3)
20 Million
particles per cubic
foot
2 mg/m³Basis

2 mg/m³

ACGIH

10 mg/m³
5 mg/m³

ACGIH
NIOSH REL

10 mg/m³
15 mg/m³

NIOSH REL
OSHA Z-1

5 mg/m³

OSHA Z-1

10 mg/m³
5 mg/m³

ACGIH
NIOSH REL

10 mg/m³
15 mg/m³

NIOSH REL
OSHA Z-1

5 mg/m³

OSHA Z-1

5 mg/m³
5 mg/m³

ACGIH
NIOSH RELInternal
OSHA Z-3

NIOSH RELAll engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
Containment technologies suitable for controlling compounds
are required to control at source and to prevent migration of
the compound to uncontrolled areas (e.g., open-facecontainment devices).
Minimize open handling.

Personal protective equipment
Respiratory protection: General and local exhaust ventilation is recommended tomaintain vapor exposures below recommended limits. Where
concentrations are above recommended limits or are
unknown, appropriate respiratory protection should be worn.
Follow OSHA respirator regulations (29 CFR 1910.134) and5 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019

use NIOSH/MSHA approved respirators. Protection provided
by air purifying respirators against exposure to any
hazardous chemical is limited. Use a positive pressure air
supplied respirator if there is any potential for uncontrolled
release, exposure levels are unknown, or any othercircumstance where air purifying respirators may not provide
adequate protection.
Hand protection
Material:

Chemical-resistant gloves

Remarks
Eye protection::

Skin and body protection:

Hygiene measures:

Consider double gloving.
Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Work uniform or laboratory coat.
Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets,
disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
If exposure to chemical is likely during typical use, provide
eye flushing systems and safety showers close to theworking place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance

:

solid

Color

:

No data available

Odor

:

No data available

Odor Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

Not applicable

6 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019

Evaporation rate:

Not applicable

Flammability (solid, gas):

May form combustible dust concentrations in air.

Flammability (liquids):

Not applicable

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapor pressure:

Not applicable

Relative vapor density:

Not applicable

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Autoignition temperature:

Not applicable:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle size:

No data available

SECTION 10. STABILITY AND REACTIVITY
Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
May form combustible dust concentrations in air.
Can react with strong oxidizing agents.

Conditions to avoid:

Incompatible materials
Hazardous decomposition::

Heat, flames and sparks.
Avoid dust formation.
Oxidizing agents
No hazardous decomposition products are known.
7 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019

products
SECTION 11. TOXICOLOGICAL INFORMATION
Information on likely routes of exposure
Inhalation
Skin contact
Ingestion
Eye contact
Acute toxicity
Not classified based on available information.
Components:
Pancrelipase:
Acute oral toxicity:

LD50 (Rat): > 10,000 mg/kg

Talc:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg
Remarks: Based on data from similar materials

Starch:Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg

Sucrose:Acute oral toxicity:

LD50 (Rat): 29,700 mg/kg

Diethyl phthalate:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 4.64 mg/l
Exposure time: 6 h
Test atmosphere: vapor

Acute dermal toxicity:

LD50 (Rat): > 11,181 mg/kg

:
:
:
:

RabbitOECD Test Guideline 404
Skin irritation
Based on data from similar materials

Skin corrosion/irritation
Causes skin irritation.
Components:
Pancrelipase:
Species
MethodResultRemarks

8 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

Talc:
SpeciesResult::RabbitNo skin irritation

Diethyl phthalate:SpeciesResult::RabbitNo skin irritation

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019

Serious eye damage/eye irritation
Causes serious eye irritation.
Components:
Pancrelipase:
ResultRemarks::

Irritation to eyes, reversing within 21 days
Based on data from similar materials

Talc:
SpeciesResult::RabbitNo eye irritation

Starch:SpeciesResult::RabbitNo eye irritation

Diethyl phthalate:SpeciesResultRemarks:::

RabbitNo eye irritation
Based on data from similar materials

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
May cause allergy or asthma symptoms or breathing difficulties if inhaled.
Components:
Pancrelipase:
Routes of exposure
SpeciesResultRemarks::::

Inhalation
Humanspositive
Based on data from similar materials

Assessment:

May cause sensitization by inhalation.

Talc:
Routes of exposure:

Skin contact
9 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

SpeciesResult::Humansnegative

Starch:Test Type
Routes of exposure
SpeciesResult::::Maximization Test
Skin contact
Guinea pig
negative

Diethyl phthalate:
Test Type
Routes of exposure
SpeciesResult::::Buehler Test
Skin contact
Guinea pig
negative

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019

Germ cell mutagenicity
Not classified based on available information.
Components:
Pancrelipase:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Method: OECD Test Guideline 471
Result: negative
Remarks: Based on data from similar materials
Test Type: In vitro mammalian cell gene mutation test
Method: OECD Test Guideline 476
Result: negative
Remarks: Based on data from similar materials
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative
Remarks: Based on data from similar materials

Talc:
Genotoxicity in vitro:

Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Result: negative

Genotoxicity in vivo:

Test Type: Chromosome aberration test in vitro
Species: Rat
Application Route: Ingestion
Result: negative

Starch:Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative

10 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019

Sucrose:Genotoxicity in vitro:

Test Type: In vitro mammalian cell gene mutation test
Result: negative

Diethyl phthalate:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Method: OECD Test Guideline 471
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Method: OECD Test Guideline 476
Result: negative
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative

Carcinogenicity
Not classified based on available information.
Components:
Talc:
Species
Application RouteExposure time
Result

:
:
:
:

Mouse
inhalation (dust/mist/fume)
2 Years
negative

Diethyl phthalate:Species
Application RouteExposure time
Result

:
:
:
:

Rat
Skin contact
103 weeks
negative

IARC

No ingredient of this product present at levels greater than or equal to 0.1% isidentified as probable, possible or confirmed human carcinogen by IARC.

OSHA

No component of this product present at levels greater than or equal to 0.1% is
on OSHA’s list of regulated carcinogens.

NTP

No ingredient of this product present at levels greater than or equal to 0.1% isidentified as a known or anticipated carcinogen by NTP.

Reproductive toxicity
Not classified based on available information.
Components:
Pancrelipase:
Effects on fertility:

Test Type: Two-generation reproduction toxicity study
Species: Rat
11 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019

Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials
Effects on fetal development:

Test Type: Embryo-fetal development
Species: Rat
Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials

Talc:
Effects on fetal development:

Test Type: Embryo-fetal development
Species: Rat
Application Route: Ingestion
Result: negative

Diethyl phthalate:
Effects on fertility:

Test Type: Two-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 416
Result: negative

Effects on fetal development:

Test Type: Embryo-fetal development
Species: Rat
Application Route: Ingestion
Result: negative
Test Type: Embryo-fetal development
Species: Rabbit
Application Route: Skin contact
Result: negative

STOT-single exposure
Not classified based on available information.
STOT-repeated exposure
Not classified based on available information.
Repeated dose toxicity
Components:
Pancrelipase:
Species
NOAEL
Application RouteExposure time
MethodRemarks

:
:
:
:
:
:

Rat
> 100 mg/kg
Ingestion
13 Weeks
OECD Test Guideline 408
Based on data from similar materials

12 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019

Starch:Species
NOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
>= 2,000 mg/kg
Skin contact
28 Days
OECD Test Guideline 410

Diethyl phthalate:Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
150 mg/kg
Ingestion
16 WeeksAspiration toxicity
Not classified based on available information.
SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Pancrelipase:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): > 100 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203
Remarks: Based on data from similar materials

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 10 - 100 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202
Remarks: Based on data from similar materials

Toxicity to algae/aquaticplants:

ErC50 (Pseudokirchneriella subcapitata (green algae)): > 1 10 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
NOEC (Desmodesmus subspicatus (green algae)): > 1 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials

Talc:
Toxicity to fish:

LC50 (Brachydanio rerio (zebrafish)): > 100,000 mg/l
Exposure time: 24 hDiethyl phthalate:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): 12 mg/l
13 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019

Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

LC50 (Daphnia magna (Water flea)): 90 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Desmodesmus subspicatus (green algae)): 45 mg/l
Exposure time: 72 h
EC10 (Desmodesmus subspicatus (green algae)): 9 mg/l
Exposure time: 72 h

Toxicity to fish (Chronic toxicity):

Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)

NOEC (Cyprinus carpio (Carp)): 5 mg/l
Exposure time: 28 d
NOEC (Daphnia magna (Water flea)): 25 mg/l
Exposure time: 21 d

Persistence and degradability
Components:
Pancrelipase:
Biodegradability:

Result: Readily biodegradable.

Diethyl phthalate:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 94.6 %Exposure time: 28 d

Pancrelipase:
Partition coefficient: noctanol/water:log Pow: < 4

Sucrose:Partition coefficient: noctanol/water:

Pow: < 1

Diethyl phthalate:Partition coefficient: noctanol/water:log Pow: 2.2

Bioaccumulative potential
Components:

Mobility in soil
No data available
Other adverse effects
No data available

14 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019

SECTION 13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Dispose of in accordance with local regulations.
Do not dispose of waste into sewer.
Empty containers should be taken to an approved waste
handling site for recycling or disposal.
If not otherwise specified: Dispose of as unused product.

SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDG
Not regulated as a dangerous good
IATA-DGR
Not regulated as a dangerous good
IMDG-CodeNot regulated as a dangerous goodTransport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
Domestic regulation
49 CFR
UN/ID/NA number
Proper shipping name

:
:

Class
Packing group
LabelsERG Code
Marine pollutant
Remarks

:
:
:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(Diethyl phthalate)
9
III
CLASS 9171
noTHE ABOVE INFORMATION ONLY APPLIES TO PACKAGESIZES WHERE THE HAZARDOUS SUBSTANCE MEETSTHE REPORTABLE QUANTITY.

Special precautions for user
The transport classification(s) provided herein are for informational purposes only, and solely
based upon the properties of the unpackaged material as it is described within this Safety Data
Sheet. Transportation classifications may vary by mode of transportation, package sizes, andvariations in regional or country regulations.
SECTION 15. REGULATORY INFORMATIONCERCLA Reportable Quantity
Components

CAS-No.

Diethyl phthalate

84-66-2

15 / 18

Component RQ
(lbs)
1000

Calculated product RQ
(lbs)
47619

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019

SARA 304 Extremely Hazardous Substances Reportable Quantity
This material does not contain any components with a section 304 EHS RQ.
SARA 302 Extremely Hazardous Substances Threshold Planning Quantity
This material does not contain any components with a section 302 EHS TPQ.
SARA 311/312 Hazards:

Combustible dust
Respiratory or skin sensitization
Skin corrosion or irritation
Serious eye damage or eye irritation

SARA 313:

This material does not contain any chemical components withknown CAS numbers that exceed the threshold (De Minimis)
reporting levels established by SARA Title III, Section 313.

US State Regulations
Pennsylvania Right To Know
Pancrelipase
Cellacefate
Talc
SucroseStarchDiethyl phthalate

53608-75-6
9004-38-0
14807-96-6
57-50-1
9005-25-8
84-66-2

California List of Hazardous Substances
Talc
Diethyl phthalate
Polyvinyl pyrrolidone

14807-96-6
84-66-29003-39-8

California Permissible Exposure Limits for Chemical Contaminants
Talc
SucroseStarchDiethyl phthalate

14807-96-6
57-50-1
9005-25-8
84-66-2

The ingredients of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Further information

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

NFPA 704:

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019
HMIS® IV:

Flammability

HEALTH

2
Health20Special hazard*

2

FLAMMABILITY

2

PHYSICAL HAZARD

0

Instability

HMIS® ratings are based on a 0-4 rating
scale, with 0 representing minimal hazards or risks, and 4 representing significant hazards or risks. The "*" represents
a chronic hazard, while the "/" represents
the absence of a chronic hazard.

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
NIOSH REL
: USA. NIOSH Recommended Exposure Limits
OSHA Z-1: USA. Occupational Exposure Limits (OSHA) - Table Z-1 Limits for Air Contaminants
OSHA Z-3: USA. Occupational Exposure Limits (OSHA) - Table Z-3 Mineral Dusts
ACGIH / TWA: 8-hour, time-weighted average
NIOSH REL / TWA: Time-weighted average concentration for up to a 10-hour
workday during a 40-hour workweek
OSHA Z-1 / TWA: 8-hour time weighted average
OSHA Z-3 / TWA: 8-hour time weighted average
AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing ofMaterials; bw - Body weight; CERCLA - Comprehensive Environmental Response, Compensation,and Liability Act; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of theGerman Institute for Standardisation; DOT - Department of Transportation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with x% response; EHS - Extremely Hazardous Substance; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; HMIS - Hazardous Materials Identification System; IARC International Agency for Research on Cancer; IATA - International Air Transport Association; IBC- International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals
in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime
Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health
Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to
50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; MSHA - Mine Safety and Health Administration; n.o.s. - Not Otherwise Specified; NFPA - National Fire Protection Association; NO(A)EC - No Observed (Adverse)
Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable
17 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Pancrelipase (High / Low Lipase) Formulation
Version
1.7

Revision Date:
09/30/2023

SDS Number:
5322088-00008

Date of last issue: 04/04/2023
Date of first issue: 11/22/2019

Effect Loading Rate; NTP - National Toxicology Program; NZIoC - New Zealand Inventory ofChemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; RCRA - Resource Conservation and Recovery Act;REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RQ - Reportable
Quantity; SADT - Self-Accelerating Decomposition Temperature; SARA - Superfund Amendments and Reauthorization Act; SDS - Safety Data Sheet; TCSI - Taiwan Chemical SubstanceInventory; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act(United States); UN - United Nations; UNRTDG - United Nations Recommendations on theTransport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative

Sources of key data used tocompile the Material Safety
Data Sheet:Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

Revision Date:

09/30/2023

The information provided in this Safety Data Sheet is correct to the best of our knowledge,
information and belief at the date of its publication. The information is designed only as a
guidance for safe handling, use, processing, storage, transportation, disposal and release andshall not be considered a warranty or quality specification of any type. The information provided
relates only to the specific material identified at the top of this SDS and may not be valid when the
SDS material is used in combination with any other materials or in any process, unless specified
in the text. Material users should review the information and recommendations in the specificcontext of their intended manner of handling, use, processing and storage, including anassessment of the appropriateness of the SDS material in the user’s end product, if applicable.
US / Z8

18 / 18